23/12/2014
Workshop for Caribbean countries to promote the
development and implementation of Conformity
Assessment programmes
St. Augustine (Trinidad and Tobago)
2-4 December 2014
PART 2
Requirements for Accreditation Bodies
and Testing Laboratories
Presented by
Andrew Kwan
ITU Consultant
St Augustine, Trinidad and Tobago, 2-4 December 2014
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PRESENTATION OVERVIEW
 Conformance Testing
 Requirements for Accreditation
Bodies
 Requirements for Testing
Laboratories
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Brasilia, Brazil, 12-15 June, 2012
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Conformance Testing
Accreditation body
Assess competence
Testing Laboratories
Assess conformity
Products
Supplier
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Conformance Testing
 ISO and IEC jointly develop international
standards through the ISO Committee on
Conformity Assessment (CASCO). These
documents are referred to as the CASCO
toolbox
 CASCO toolbox consists of documents
covering vocabulary, principles and common
elements of conformity assessment, code of
good practice, product certification, system
certification, certification of persons, marks of
conformity, testing, calibration, inspection,
supplier’s declaration of conformity,
accreditation, peer assessment and mutual
recognition arrangements
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Conformance Testing
CASCO Toolbox (1) includes:
ISO/IEC 17000:2004
Conformity assessment –Vocabulary and general principles
ISO/IEC 17011: 2004
Conformity assessment – General requirements for accreditation
bodies accrediting conformity assessment bodies
ISO/IEC 17020: 2012
General criteria for the operation of various types of bodies
performing inspection
ISO/IEC 17021: 2011
Conformity assessment – Requirements for bodies providing audit
and certification of management systems
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Conformance Testing
CASCO Toolbox (2) includes:
ISO/IEC 17024: 2012
Conformity assessment – General requirements for bodies operating
certification of persons
ISO/IEC 17025:2005/Cor 1:2006
General requirements for the competence of testing and calibration
laboratories
ISO/IEC 17030: 2003
Conformity assessment – General requirements for third-party marks of
conformity
ISO/IEC 17040: 2005
Conformity assessment – General requirements for peer assessment of
conformity assessment bodies and accreditation bodies
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Conformance Testing
CASCO Toolbox (3) includes:
ISO/IEC 17050: 2010
Conformity assessment – Supplier’s declaration of conformity
ISO/IEC 17065:2012
General requirements for bodies operating product certification systems
ISO/IEC Guide 17068:2013
Arrangements for the recognition and acceptance of conformity
assessment results
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation body
 Management
 Human resources
 Accreditation process
 Responsibilities of the accreditation body and
the Conformity Assessment Bodies (CAB)
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation body
 A registered legal entity
 Structure
 Authority (generally derived from government) and
be responsible for decisions on accreditation
 Duties, responsibilities and authorities of senior
management documented, including decisions on
accreditation; finance; policies; contracts etc
 Access to expertise related to accreditation
(committees)
 Rules for appointment, terms of reference and
operation of committees
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation body (cont’d)
 Impartiality
 Assessors do not make decisions on accreditation
 Do not offer conformity assessment services or
consultancy
 Confidentiality
 Safeguard the confidentiality of information gathered
in the process of accreditation
 Liability and financing
 Accreditation activities
 Described and referring to relevant international
standards and guides
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Management
 Management system
 Policies including a quality policy and objectives
defined and documented
 Document control
 Procedures to control all documents
 Documents approval
 Updates and review
 Change and version control
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Management (cont’d)
 Records
 Procedures to identify, collect, index, access, file,
store, maintain and dispose records
 Nonconformities and corrective actions
 Procedures to identify and manage nonconformities
 Preventive actions
 Procedures to identify opportunities for improvement
and to take preventive actions
 Internal audits
 Procedures for internal audit to verify conformity to
17011
 At least once a year
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Management (cont’d)
 Management review
 Senior management to review management system
at least once a year
 Review includes results of audit; results of peer
evaluation; new areas of accreditation; trends in
nonconformities; status of preventive and corrective
actions; appeals and analysis of complaints
 Complaints
 Procedures to deal with complaints
 Validity of complaints
 Complaints concerning an accredited CAB to be first
addressed by the CAB
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Human resources
 Personnel associated with the accreditation
body
 Competent with necessary education, training,
technical knowledge, skill and experience
 Access to assessors
 Personnel involved in the accreditation process
 Qualification, experience and competence stated for
each activity
 Procedures for selecting, training and approval of
assessors and experts
 Assessors with relevant accreditation assessor
training and knowledge of assessment methods
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Human resources (cont’d)
 Monitoring
 Procedures to monitor the performance and
competence of personnel
 Evaluate performance of assessors. On-site
observation every three years
 Personnel records
 Maintain records of qualifications, training,
experience and competence of persons involved in
accreditation
 Maintain up-to-date records on assessors and
experts
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Accreditation criteria and information
 Criteria for accreditation of CABs documented
 Information on assessment and accreditation
processes, requirements for accreditation, fees,
procedures for lodging complaints and appeals,
 Application for accreditation
 Resource review
 Ability to carry out the assessment
 Ability to carry out initial assessment in a timely
manner
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Subcontracting the assessment
 Decision-making cannot be subcontracted
 Contracting of external assessors is not
subcontracting
 Takes full responsibility subcontracted assessments
 Written consent of CAB to use a particular
subcontractor
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Preparation for assessment
Preliminary visit before initial assessment
Appoints assessment team with lead assessor
Team members cannot provide consultancy to CAB
Names of team members supplied to CAB in advance
to allow the CAB to object
 Task of assessment is to review documents collected
from CAB and to conduct on-site assessment
 Assessment team witness a representative number
of samples of the conformity assessment services
 Visits to all premises of the CAB which perform key
activities covered by the scope of accreditation.




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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Document and record review
 Assessment team reviews all documents and records
provided by the CAB
 If nonconformities are found during review, on-site
visit may not go ahead and nonconformities are
reported to CAB in writing.
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 On-site assessment
 Opening meeting to define purpose of assessment
and accreditation criteria and to confirm schedule
and scope of assessment
 Conduct assessment at premises from which one or
more key activities are performed
 Witness the performance of a representative number
of staff of CAB
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Analysis of findings and assessment report
 Review of documents and on-site assessment to
determine competence and conformity of CAB with
requirements of accreditation
 If assessment team cannot reach a conclusion, it will
refer back to accreditation body for clarification
 Assessment team meets with CAB prior to leaving
the site and provides a written and or oral report on
its findings
 Written assessment report provided to the CAB for
comments
 Assessment team to provide detail report on
assessment to accreditation decision-makers
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Decision-making and granting accreditation
 Can use results of assessment of another
accreditation body as long as it is 17011 compliant
 Accreditation certificate with logo of accreditation
body, unique accreditation number of the accredited
CAB, effective dates, scope of accreditation
 Unique information on the CABs e.g. For testing
laboratories, the tests performed, products tested
and methods used
 Appeals
 Procedures to address appeals
 Appoint competent and independent person to
investigate appeals
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Reassessment and surveillance
 Reassessment is similar to initial assessment
 Surveillance – monitor the continued fulfillment of
the accredited CAB of requirement of accreditation,
includes surveillance on-site assessments and other
surveillance activities such as enquires, review of
declarations of CAB on scope, request to CAB for
documents and records
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Reassessment and surveillance (cont’d)
 Reassessment at least every 2 years
 If reassessment and surveillance are used,
reassessment is done at least every 5 years and
surveillance on-site assessment is at least every 2
years.
 First surveillance on-site assessment no later than
12 months from initial accreditation
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Extending accreditation
 Extension of scope of accreditation may require
reassessment
 Suspending, withdrawing or reducing
accreditation
 Accreditation of CAB can be suspended, withdrawn
or reduced if the CAB persistently failed to meet the
requirements of accreditation or to abide by the rules
of accreditation
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Requirements for Accreditation
Bodies (ISO/IEC 17011)
 Accreditation process
 Responsibilities of the accreditation body
 Give notice of changes to its requirements for
accreditation
 Make public information on the current status of the
accreditations it has granted to CABs
 Responsibilities of the CAB
 Fulfill continually the requirements for accreditation
 Cooperate with accreditation body to verify
fulfillment of requirements for accreditation
 Inform accreditation body of changes relevant to its
accreditation
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 General
 Organization and Management
 Management requirements
 Technical requirements
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 General
 ISO/IEC 17025 addresses both management




system elements and technical competence in
a systematic and consistent way
Quality systems elements in line with ISO
9001
Emphasis on responsibility of senior
management
Explicit requirements for continued
improvement of the management system
Emphasizes communication with customers
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Organization and Management
Organization
 The laboratory must be part of an organization
that is an entity which can be held legally
responsible
 Responsible for meeting requirements of:
 ISO/IEC 17025
 The needs of its clients
 Regulatory authorities
 The management system shall cover work at:
 Permanent facilities
 Sites away from permanent facilities
 Associated temporary or mobile facilities
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Organization and Management
Lab requirements
 Have managerial and technical personnel with
authority and resources needed to carry out
their duties including:
 implementation, maintenance and improvement of
the management system
 Have policies and procedures for the
protection of client’s confidential information,
proprietary rights including:
 Electronic storage and transmission of results
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Organization and Management
Lab requirements
 Define organization and management
structure including:
 Relationship within a larger organization
 Relationship between qualify management, technical
operation and support services
 Define the responsibility, authority and interrelationship of personnel involved in
management, performance or verification of
work affecting the quality of tests and/or
calibrations
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Organization and Management
Lab requirements
 Technical management with overall
responsibility for:
 Technical operation
 Provision of resources needed to meet the required
quality of laboratory operation
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Management system
 Document policies, procedures and
instructions on the laboratory’s scope of
activities
 Quality policy defined in a quality manual and
issued under authority of top management
with:
 Statement on standard of service
 Quality objectives must be measurable
 Roles and responsibility of technical
management and quality manager defined in
the qualify manual
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Document control
 Establish and maintain procedures to control
all documents as part of its management
system
 Document approval and issue:
 Documents reviewed and approved by authorized
personnel
 A master list established and readily available
 Authorized editions of documents available at all
locations where operations essential to effective
operation of the laboratory are performed
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Document control
 Document approval and issue:
 Documents reviewed and revised periodically for
suitability
 Documents changes:
 Changes to documents reviewed by the same
function that performed the original review
 Procedures and authorities for hand written
amendments defined
 Procedures to describe to make and control changes
in computerized systems
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Review of request, tenders and contracts
 Procedures for review to ensure that:
 Requirements including methods to be used are
adequately defined and understood
 Capability and resources to meet the requirements
 Appropriate tests or calibrations are selected capable
of meeting the customer’s requirements
 Any differences between the request or tender
and the contract must be resolved before
commencing work
 Maintain records of review and discussions
with customers
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Subcontracting
 Subcontracting work be placed with a
competent laboratory (e.g. one which is
ISO/IEC 17025 compliant)
 Advise in writing the customer of
subcontracting of tests and, where appropriate
obtain their approval
 Responsible to the customer for the
subcontractor’s work
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Purchasing services and supplies
 Have procedures for selecting and purchasing
of services and supplies affecting quality of
work
 Purchased supplies not to be used until they
have been verified as complying with
requirements
 Purchasing documents adequately describe the
services and products ordered and they are
reviewed and approved for technical content
before being released
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Service to customer
 Seek feedback both positive and negative
from customers
 Analyse feedback for improvement to the
management system
Complaints
 Procedure for resolution of complaints
 Maintain records of all complaints,
investigations and corrective actions taken
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Control of nonconforming testing
 Have policy and procedures to be
implemented in the case of the testing does
not conform to its own procedures or
customer’s requirements
 Policy and procedures ensure that:
 Responsibilities and authorities for taking action are
designated
 Corrective action is taken immediately with decision
on the acceptability of the nonconforming work
 Customer is notified and work is recalled
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Corrective actions
 Have procedures for corrective action and
appropriate authorities designated to
implement corrective action
 Corrective action procedures include:
 Root cause analysis
 Selection and implementation of corrective actions
 Additional audits to ensure compliance with own
policies and procedures or compliance with ISO/IEC
17025
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Preventive actions
 A proactive process to identify opportunities
for improvement, not a reaction to the
identification of problems
 Plans to be developed, implemented and
monitored to identify improvement
opportunities or required preventive actions
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Control of records (General)
 Have procedures to identify, collect, index,
access, file, maintain and dispose of quality
and technical records
 Specify retention times for records
 Records to be readily retrievable and stored in
a manner to prevent damage and loss
 Records to be held secure and in confidence
 Procedures to back up records stored
electronically and to prevent unauthorized
access to or amendment of such records
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Control of records (Technical)
 Records retained for a defined period of time
including:






Original observations
Derived data
Sufficient information to establish audit trail
Staff records
Copy of test report or calibration certificate issued
Calibration records
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Control of records (Technical)
 Test or calibration records contain sufficient
information to enable:
 Identification of factors contributing to measurement
uncertainty
 Identification of personnel responsible for the
sampling and checking of results
 Mistakes in records be crossed through but
still legible with the correction entered next to
the original information
 Alteration signed or initialled by person
making the correction
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Internal audits
 Conducted periodically and within a
predetermined schedule and procedure
 Quality manager responsible for planning and
carrying out internal audits
 Covers all elements of management system
including testing activities
 Records kept of the area of activity audited,
the audit findings and corrective actions
 Conduct follow up to the audit to verify the
implementation and effectiveness of corrective
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Management reviews
 Management reviews are conducted
periodically (typically once per year) with a
predetermined schedule and procedure to:
 Review the effectiveness and suitability of its
management system and/or testing or calibration
activities
 Introduce necessary changes or improvement
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Management requirements
Management reviews
 Management reviews cover:







Reports from managerial and supervisory personnel
Outcome of recent internal audits
Corrective and preventive actions
Assessments by external bodies
Customer feedback
Complaints
Recommendations for improvement
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
General
 Factors which determine the correctness and
reliability of tests include:
 Human, environmental conditions, test method and
method validation
 Measurement traceability, sampling and handling of
test items
 Take into account of these factors when
developing tests, procedures, training and
qualification of personnel and selection of
equipment
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Personnel
 The laboratory shall:
 Ensure the competence of all who operate
equipment, perform tests, evaluate results and sign
test reports and calibration certificates
 Have policies and procedures for training programs
and evaluation of their effectiveness
 Management to authorize specific personnel:
 To perform particular types of sampling and tests
 To issue test reports and calibration certificates
 Maintain records of relevant authorizations,
competence, qualifications and experience for all
personnel including those under contracts
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Accommodation and environmental conditions
 Laboratory facilities (energy source, lighting,
environmental) be suitable for performing
tests correctly
 Document technical requirements for
accommodation and environmental conditions
that can affect results
 Effective separation between incompatible
activities
 Control access to and use of areas affecting
quality of testing
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Test and calibration methods and method validation
 Use appropriate methods and procedures for all tests in
its scope
 Deviation from test methods documented, technical
justified, authorized and accepted by the customer
 Test methods published in international, regional or
national standards are preferred
 Use of non-standard method shall:
 Be subject to agreement with the customer
 Include a clear specification of the customer’s requirement
and the purpose of the test or calibration
 Be validated appropriately before use
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Estimation of uncertainty of measurement
 Procedures for estimation of uncertainty for
types of tests and calibrations
 If test method may preclude rigorous analysis,
the laboratory shall:
 Attempt to identify all components of uncertainty
 Make a reasonable estimation based on knowledge of
the performance of the method and on the
measurement scope
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Control of data
 Calculation and data transfers subject to
appropriate checks
 Computer software suitably validated
 Procedures for protecting data including
integrity and confidentiality of data collection,
data storage, data transmission and data
processing
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Equipment
 Furnished with equipment for correct
performance of tests
 Equipment used outside of its permanent
control meets appropriate requirements of
ISO/IEC 17025
 Equipment which has been subject to
overloading or mishandling or found to be
defective shall be:
 Taken out of service
 Isolated or clearly marked as being out of service
until it has been repaired and calibrated
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Equipment
 Equipment to be labelled with its calibration
status
 When for whatever reason, equipment goes
outside the control of the laboratory, check its
function and calibration status before it is
returned to service
 Conduct intermediate checks when required
according to defined procedure
St Augustine, Trinidad and Tobago, 2-4 December 2014
Brasilia, Brazil, 12-15 June, 2012
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Measurement traceability
 Calibrate all equipment which have a
significant effect on test results
 For calibration, establish traceability of
equipment to the International System of
Units (SI) (Systeme international d’unites) by
means of an unbroken chain of calibrations or
comparisons linked to relevant primary
standards, typically through national
metrology institutes
St Augustine, Trinidad and Tobago, 2-4 December 2014
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Sampling
 Have sampling plan and procedures available
at locations where sampling is undertaken
 Record deviations, additions or exclusion from
the documented sampling procedure with
appropriate sampling data
 Record sampling procedure, identification of
the sampler, environmental conditions,
diagram and if appropriate statistics upon
which sampling is based
St Augustine, Trinidad and Tobago, 2-4 December 2014
Brasilia, Brazil, 12-15 June, 2012
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Handling of test and calibration items
 Procedures for identification, transportation,
receipt, handling, protection, storage,
retention and disposal of test items
 Consult customer before proceeding when
there is doubt about the suitability of an item
for test or test required is not specified in
sufficient detail
St Augustine, Trinidad and Tobago, 2-4 December 2014
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Reporting the results
 Report results accurately, clearly,
unambiguously and objectively and in
accordance with any specific instructions in
the test method
 Test reports include information requested by
the customer and necessary for interpretation
of the test results
St Augustine, Trinidad and Tobago, 2-4 December 2014
Brasilia, Brazil, 12-15 June, 2012
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Test reports and calibration certificates
 Test report, as a minimum contains:
A title (e.g. “Test Report” or “Calibration certificate”)
A unique identification such as the serial number
Name and address of customer
Identification of test methods used
Description of condition and unambiguous
identification of test item
 Date of receipt of test item where this is critical to
the validity and application of the results
 Date of test or calibration
 Test or calibration results with, where appropriate
the unit of measurement





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St Augustine, Trinidad and Tobago, 2-4 December 2014
Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Test reports
 Test report also contains where necessary for
interpretation of test results:
 Deviations from, additions to, or exclusions from the
test method
 Where relevant, a statement of compliance/noncompliance with requirements
 Where applicable, a statement on the estimated
uncertainty of measurement
 This statement is applicable when required for the
validity or application of results, when the customer
requires it or when it affects compliance to a
specification limit
St Augustine, Trinidad and Tobago, 2-4 December 2014
Brasilia, Brazil, 12-15 June, 2012
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Test reports
 In addition, if sampling is used, report
includes:
 Date of sampling
 Unambiguous identification of samples
 Location of sampling, including diagrams, sketches
or photographs
 Reference to sampling plan and procedures used
 Details of any environmental conditions during
sampling that may affect interpretation of results
 Any standards or specifications for sampling methods
 Any deviations, additions or exclusions from the
specification concerned
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St Augustine, Trinidad and Tobago, 2-4 December 2014
Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Calibration certificates
 Calibration certificates contain:
 Conditions under which calibrations were made
 Uncertainty of measurement and/or statement of
compliance
 Evidence that measurements are traceable
St Augustine, Trinidad and Tobago, 2-4 December 2014
Brasilia, Brazil, 12-15 June, 2012
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Opinion and interpretation
 When opinions and interpretations are
included, the laboratory shall:
 Document the basis on which they were made
 Clearly mark as such in the report
Testing and calibration results obtained from
subcontractors
 When test report contains results of tests
performed by subcontractors, these results
shall be clearly identified
St Augustine, Trinidad and Tobago, 2-4 December 2014
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Requirements for Testing
Laboratories (ISO/IEC 17025)
 Technical requirements
Amendments to test reports & calibration
certifications
 Material amendments to test report after issue
shall be made only in the form of a further
document or data transfer
 It includes the statement:
 “Supplement to Test Report (or Calibration
Certificate), serial number….” or equivalent wording
 A new report shall be uniquely identified and
contain a reference to the original that it
replaces
St Augustine, Trinidad and Tobago, 2-4 December 2014
Brasilia, Brazil, 12-15 June, 2012
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Requirements for Accreditation Bodies
and Testing Laboratories
Thank you for your attention
Andrew Kwan
akwan68@gmail.com
St Augustine, Trinidad and Tobago, 2-4 December 2014
Brasilia, Brazil, 12-15 June, 2012
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